Full Description

Job Summary

We are pleased to advertise the vacancy of Quality Assurance Manager for the Clinical Research Directorate. Based within the Newcastle Joint Research Office (NJRO), the post holder will be responsible for the oversight of the department's Quality Management System (QMS) and annual audit plan. The post holder will support several teams across the NJRO with regulatory and governance affairs and provide strategic input on the future direction of the department.

The post holder will also interact with all delivery teams across the directorate, providing advice, support and key decision making, in relation to quality and audit. The post holder will also lead a team of quality assurance specialist in the areas of Good Clinical Practice (GCP) and Human Tissue Authority (HTA). A key element of the role is to support the Directorate with regulatory inspections and provide advice across several key stakeholders, within Newcastle Hospitals but also across regional partner organisations.

Interview Date Thursday 29 January 2026 37 Hours 30 Minutes/Week You will be redirected to Trac to apply for the vacancy. Please expand the job details section and read all of the information before applying for the vacancy

NO AGENCIES PLEASE

Main duties of the job

Ensure that the annual audit plan is approved and completed Provide data in relation to key audit findings and solutions to the Senior Management Team Ensure that the quality policy and manual are maintained and fir-for-purpose Provide support and advice for processes and standard operating procedures Support the NJRO Lead with key decision making and strategy Provide line manager for a mixed team of Newcastle Hospitals and Newcastle University staff Report to appropriate committees and boards Provide key advice and support for regulatory inspections Be a key player in Corrective and Preventative planning Ensure risk assessments are completed for particular regulatory and governance matters Work closely with external stakeholders to ensure quality across partners within the North East and North Cumbria Support the Directorates approach to digitalisation

About Us

As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.

With around 2 million contacts with patients every year, we deliver care from

Royal Victoria Infirmary (RVI) Freeman Hospital Newcastle Dental Hospital Cramlington Manor Walks Urgent treatment centres Newcastle Fertility Centre Northern Centre for Cancer Care, North Cumbria Northern Genetics Service

These include a range of flagship services which deliver cutting-edge care (supported by state-of-the-art diagnostic services in both radiology and pathology) and are a catalyst for innovation to support pioneering clinical practice in the NHS.

We also have offices at Regent Point in Gosforth and community sites.

Please see attached information on what Staff Benefits we have to offer at our Trust under 'Documents to download' or 'Supporting documents'.

For further information on The Newcastle upon Tyne Hospitals NHS Foundation Trust please visit: Careers | Newcastle Hospitals | NHS | Newcastle Hospitals and Newcastle Hospitals NHS Foundation Trust

Details

Date posted

02 January 2026

Pay scheme

Agenda for change

Band

Band 8a

Salary

£55,690 to £62,682 a year per annum

Contract

Permanent

Working pattern

Full-time

Reference number

317-2025-48-025

Job locations

Regent Point

317 Regent Point

NE3 3HD

Job Description

Job responsibilities

The Post Holder Will Support The Head Of The Joint Research Office In Leading, Developing And Coordinating Quality Management Systems In Support Of The Research Activity Taking Place On Behalf Of The Trust, Ensuring Patient Safety And Research Data Validity, Including

Ensuring all processes contributing to the performance of any trials are conducted in accordance with ICH-GCP guidelines, relevant SOPs and other regulations. Developing a Quality Management System, the focus of which is to develop, perform and manage quality assurance-relates activities from policy level through to coordinating appropriate SOP development, ensuring compliance via undertaking a risk-adaptive audit programme Ensure that audit results are formally and consistently recorded and reported and that corrective/preventive actions have been requested and documented effectively Training of JRO staff and others as required (either directly or indirectly) regarding GCP, QA and regulatory audits

The post holder will ensure that Sponsor and Regulatory audits are effectively executed and provide support and direction during the hosting of such audits as necessary, assisting the Research Governance Manager as required

Job Description

The post holder will support the Head of the Joint Research Office in leading, developing and coordinating quality management systems in support of the research activity taking place on behalf of the Trust, ensuring patient safety and research data validity, including

Ensuring all processes contributing to the performance of any trials are conducted in accordance with ICH-GCP guidelines, relevant SOPs and other regulations. Developing a Quality Management System, the focus of which is to develop, perform and manage quality assurance-relates activities from policy level through to coordinating appropriate SOP development, ensuring compliance via undertaking a risk-adaptive audit programme Ensure that audit results are formally and consistently recorded and reported and that corrective/preventive actions have been requested and documented effectively Training of JRO staff and others as required (either directly or indirectly) regarding GCP, QA and regulatory audits

The post holder will ensure that Sponsor and Regulatory audits are effectively executed and provide support and direction during the hosting of such audits as necessary, assisting the Research Governance Manager as required

Person Specification

KNOWLEDGE

Essential

Awareness of fundamental national and local NHS and R&D policies Evidence of relevant continuous professional development

Essential

SKILLS

Excellent interpersonal and communication skills Organisation and planning skills Leadership and management skills Negotiation, persuasion and problem-solving skills Project management skills and knowledge Research and audit skills Broad IT skills Service improvement/change management skills Well-developed report writing and analytical and presentation skills

Essential

EXPERIENCE

Extensive theoretical and practical experience of research governance, audit and policy development in a range of settings to Masters level or equivalent Proven experience in a GCP environment and/or quality setting , including policy developments Experience of preparing for external inspection Experience of monitoring compliance with national risk management/quality standards Ability to work strategically

Desirable

Experience in a corporate leadership role Extensive of conducting pharmacovigilance audits

Essential

QUALIFICATIONS

Masters level qualification or equivalent qualification or equivalent experience

Person Specification

KNOWLEDGE

Essential

Masters level qualification or equivalent qualification or equivalent experience

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Additional information

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Address

Regent Point

317 Regent Point

NE3 3HD

Employer's website

https: //careers.nuth.nhs.uk/why-us (Opens in a new tab)

Employer details

Employer name

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Address

Regent Point

317 Regent Point

NE3 3HD

Employer's website

https: //careers.nuth.nhs.uk/why-us (Opens in a new tab)

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